Randomized supplementation of 4000 IU vitamin D 3 daily vs placebo on the prevalence of anemia in advanced heart failure: the EVITA trial.

Autor: Ernst JB; Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, D-32545, Bad Oeynhausen, Germany., Prokop S; Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, D-32545, Bad Oeynhausen, Germany., Fuchs U; Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, D-32545, Bad Oeynhausen, Germany., Dreier J; Institute for Laboratory and Transfusion Medicine, Heart- and Diabetes Center NRW, Ruhr University Bochum, Bochum, Bad Oeynhausen, Germany., Kuhn J; Institute for Laboratory and Transfusion Medicine, Heart- and Diabetes Center NRW, Ruhr University Bochum, Bochum, Bad Oeynhausen, Germany., Knabbe C; Institute for Laboratory and Transfusion Medicine, Heart- and Diabetes Center NRW, Ruhr University Bochum, Bochum, Bad Oeynhausen, Germany., Berthold HK; Department of Internal Medicine and Geriatrics, Bielefeld Evangelical Hospital (EvKB), Bielefeld, Germany., Pilz S; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria., Gouni-Berthold I; Polyclinic for Endocrinology, Diabetes and Preventive Medicine (PEDP), University of Cologne, Cologne, Germany., Gummert JF; Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, D-32545, Bad Oeynhausen, Germany., Börgermann J; Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, D-32545, Bad Oeynhausen, Germany., Zittermann A; Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, D-32545, Bad Oeynhausen, Germany. azittermann@hdz-nrw.de.
Jazyk: angličtina
Zdroj: Nutrition journal [Nutr J] 2017 Aug 23; Vol. 16 (1), pp. 49. Date of Electronic Publication: 2017 Aug 23.
DOI: 10.1186/s12937-017-0270-5
Abstrakt: Background: Low 25-hydroxyvitamin D (25OHD) levels (< 75 nmol/l) are inversely associated with anemia prevalence. Since anemia and low 25OHD levels are common in patients with heart failure (HF), we aimed to investigate whether vitamin D supplementation can reduce anemia prevalence in advanced HF.
Methods: EVITA (Effect of Vitamin D on Mortality in Heart Failure) is a randomized, placebo-controlled clinical trial in patients with initial 25OHD levels < 75 nmol/l. Participants received either 4000 IU vitamin D 3 daily or a matching placebo for 36 months. A total of 172 patients (vitamin D group: n = 85; placebo group: n = 87) were investigated in this pre-specified secondary data analysis. Hemoglobin (Hb) and other hematological parameters were measured at baseline and study termination. Assessment of between-group differences in anemia prevalence and Hb concentrations was performed at study termination, while adjusting for baseline differences.
Results: In the vitamin D and placebo group, baseline proportions of patients with anemia (Hb < 12.0 g/dL in females and < 13.0 g/dL in males) were 17.2% and 10.6%, respectively (P = 0.19). At study termination, the proportion of patients with anemia in the vitamin D and placebo groups was 32.2% and 31.8%, respectively (P > 0.99). There was no between-group difference in change in the Hb concentrations (- 0.04 g/dL [95%CI:-0.53 to 0.45 g/dL]; P = 0.87). Results regarding anemia risk and Hb concentrations were similar in the subgroup of patients with chronic kidney disease (vitamin D group: n = 26; placebo group: n = 23). Moreover, results did not differ substantially when data analysis was restricted to patients with deficient baseline 25OHD levels.
Conclusions: A daily vitamin D supplement of 4000 IU did not reduce anemia prevalence in patients with advanced HF. Data challenge the clinical relevance of vitamin D supplementation to increase Hb levels.
Trial Registration: The study was registered at EudraCT (No. 2010-020793-42) and clinicaltrials.gov ( NCT01326650 ).
Databáze: MEDLINE